MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2017-07-10 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR 37601 manufactured by Medtronic Neuromodulation.
[79507543]
Please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature. Information references the main component of the system involved in the reported event; other applicable components are: product id 3389 lot# unknown serial# implanted: explanted: product type lead. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[79507544]
Richieri, r. , borius, py. , cermolacce, m. , millet, b. , lancon, c. , regis, j. A case of recovery after delayed intracranial hemorrhage after deep brain stimulation for treatment-resistant depression. Biol psychiatry. 2017. Doi: 10. 1016/j. Biopsych. 2017. 04. 009 summary/reported event: a (b)(6) male patient who had received bilateral nucleus accumbens (na) deep brain stimulation (dbs) for treatment resistant depression presented 8 days post-implant with an acute confusional syndrome with aphasia, psychomotor retardation, slurred speech, and a frontal syndrome with predominant apathy. A ct scan showed a voluminous left frontal hematoma along the electrode (diameter 55 mm) with perihematomal edema, a deletion of cortical sulci, and a mild deflection of the midline. His intracranial hemorrhage (ich) was managed conservatively, without surgical evacuation, and it resolved spontaneously. After 1 month, computed tomography showed a resorption of the hematoma with the presence of a sequellar hypodense range. No mass effect remained, and the dbs leads did not shift away from the original target. It was noted that the symptoms entirely recovered after a 3-month rehabilitation course. It was not possible to ascertain specific device information (i. E. Serial numbers) from the article or to match the reported event with any previously reported event.
Patient Sequence No: 1, Text Type: D, B5
[98561006]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[98561007]
Additional information received from the corresponding author reported that the patient? S bmi was (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[99260216]
Supplemental being sent to note additional follow-up providing the date of the event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007566237-2017-02734 |
| MDR Report Key | 6697536 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2017-07-10 |
| Date of Report | 2017-08-29 |
| Date of Event | 2014-09-09 |
| Date Mfgr Received | 2017-07-31 |
| Date Added to Maude | 2017-07-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA WOODWARD CLARK |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635263920 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE NE |
| Manufacturer City | MINNEAPOLIS MN 554211200 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 554211200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN IMPLANTABLE NEUROSTIMULATOR |
| Generic Name | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Product Code | MFR |
| Date Received | 2017-07-10 |
| Model Number | 37601 |
| Catalog Number | 37601 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-10 |